Duns Number:021192653
Device Description: AS-6430 Oral H2S Organisms Agar with Lead Acetate (OHO-C) is intended for the identificati AS-6430 Oral H2S Organisms Agar with Lead Acetate (OHO-C) is intended for the identification of volatile sulfur compound, primarily hydrogen sulfide, producing bacteria found in clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plates. Slightly turbid light yellow. 4 plates per pack.
Catalog Number
AS-6430
Brand Name
PRAS Oral H2S Organisms Agar with Lead Acetate (OHO-C)
Version/Model Number
AS-6430
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
97b2dcb9-b3ce-4914-a680-1119ce4be4b6
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 148 |